Transfer of Regulatory Responsibility From the Center for Devices and Radiological Health to the Center for Biologics Evaluation and Research; Medical Maggots and Medicinal Leeches
On December 30, 2024, medical maggots and medicinal leeches under product codes NQK and NRN, respectively, were transferred from CDRH to CBER for regulation, as these are living organisms that more closely align with products regulated by CBER.
The transferred products are listed in the table below with their corresponding new CBER 510(k) number. The list of new CBER 510(k) numbers also include links to supporting documents (e.g., administrative letter, original clearance letter, indications for use, 510(k) summary). The 510(k) holders for the transferred products were informed of their new CBER 510(k) numbers via letter. Submissions, communications, and required reports for these products should be directed to CBER.
Applicants citing any of the transferred products below as a predicate(s) when submitting a new 510(k) premarket notification for medical maggots and medicinal leeches should refer to the CBER 510(k) number listed below.
| Former CDRH 510(k) Number | Applicant | Device Name | Decision Date | New CBER 510(k) Number |
|---|---|---|---|---|
| K033391 | RONALD A. SHERMAN | MEDICAL MAGGOTS | 1/12/2004 | BK251209 |
| K040187 | RICARIMPEX SAS | MEDICINAL LEECHES | 6/21/2004 | BK251211 |
| K072438 | MONARCH LABS, LLC. | MEDICAL MAGGOTS, CREATURE COMFORTS | 10/5/2007 | BK251212 |
| K102827 | MONARCH LABS, LLC. | MEDICAL MAGGOTS, LESOC | 11/2/2011 | BK251213 |
| K123449 | BIOMONDE (A TRADING NAME OF ZOOBIOTIC LIMITED) | BIOMONDE LARVAE | 3/5/2013 | BK251214 |
| K131221 | BIOMONDE | LARVAL DEBRIDEMENT THERAPY PRODUCTS - BIOBAG 50/100/200/300/400 | 8/28/2013 | BK251216 |
| K132958 | BIOPHARM (UK) LTD. | MEDICINAL LEECHES | 2/19/2014 | BK251217 |
| K142020 | BIOMONDE | LARVAL DEBRIDEMENT THERAPY PRODUCTS - LARVAE 100/200/300 AND BIOBAG 50/100/200/300/400 | 11/5/2014 | BK251219 |
| K140907 | CAROLINA BIOLOGICAL SUPPLY CO. | LEECH, MEDICINAL | 8/7/2015 | BK251218 |
Submissions for these products should be sent to CBER's document control room in accordance with the CBER Regulatory Submissions - Electronic and Paper website. As of October 1, 2023, all 510(k) submissions submitted to CBER, unless exempted, must be submitted as electronic submissions (using the electronic Submission Template And Resource (eSTAR)) through the Electronic Submission Gateway (ESG) for CBER.
For additional information regarding this transfer, please contact CBER Office of Communication, Outreach and Development (OCOD):
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010
Resources For You
- Transfer of Regulatory Responsibility From the Center for Devices and Radiological Health to the Center for Biologics Evaluation and Research; Medical Maggots and Medicinal Leeches; FR Notice
- Devices Regulated by the Center for Biologics Evaluation and Research
- Devices Used to Process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) – Guidance for Industry and FDA Staff
- eSTAR Program